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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02271620
Other study ID # 759/25569(EC3)
Secondary ID
Status Completed
Phase N/A
First received September 9, 2014
Last updated March 21, 2018
Start date January 2014
Est. completion date April 2016

Study information

Verified date March 2018
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

- To determine prevalence of local allergic rhinitis (LAR)

- To evaluate clinical characteristic and severity of local allergic rhinitis

- To measure changing of tryptase and Specific IgE for Dermatophagoides pteronyssinus (Dp) after nasal allergen provocation test (NAPT)


Description:

Children 8-18 years with NAR were recruited. A NAPT with Der p 1 solutions (NAPT-DP) at 200 AU/mL, 600 AU/mL and 2000 AU/mL at 15-minute interval was performed, respectively. The immediate responses to NAPT-DP were assessed using symptoms score, peak nasal inspiratory flow (PNIF) and acoustic rhinometry (ARM). The nasal tryptase and sIgE-DP were measured at baseline, 15 min and 1 h after positive NAPT-DP. Allergic rhinitis (AR) patients were used as positive control.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date April 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 8 Years to 18 Years
Eligibility Inclusion Criteria:

- Children 8-15 years who were diagnosed with nonallergic rhinitis (NAR) at least 1 year

- No respiratory infections in the previous 4 weeks

- No following treatment of

- systemic corticosteroid 4 weeks

- intranasal corticosteroid 2 weeks

- oral antihistamine 1 week

- leukotriene antagonist 1 week

Exclusion Criteria:

- Patients with underlying disease:

- chronic rhinosinusitis and nasal polyp

- immunological disease

- chronic renal disease

- hepatobiliary disease

- cardiovascular disease

- cancer

- Parental withdraw consent

- Patient with uncontrolled asthma, peak expiratory flow rate (PEFR) < 80% of predicted

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
nasal allergen provocation test
nasal allergen provocation test

Locations

Country Name City State
Thailand Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University Bangkok
Thailand Division of allergy and immunology, Department of pediatric, Siriraj Hospital Bangkoknoi Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary prevalence of local allergic rhinitis (LAR) positive nasal allergen provocation test with Der p1 1 year